Australia's Therapeutic Goods Administration (TGA) has relaxed regulations for psychedelic-assisted therapy, permitting psychiatrists to leave the room after administering MDMA or psilocybin. A therapist—such as a clinical psychologist, doctor, nurse with mental health experience, or occupational therapist—must remain with the patient, along with a second staff member.
Background of Psychedelic Research
Psychedelics like psilocybin and MDMA have been used for millennia in various cultures for healing. Modern Western research began in 1938 when Swiss chemist Albert Hofmann synthesized LSD. The 1940s–1960s, often called the golden age of psychedelic research, saw thousands of studies. However, political pressures and the war on drugs halted research in the 1960s, and in 1967 these substances were placed in Schedule 1 of the UN Convention on Drugs, deemed to have no medical use.
Australia's 2023 Decision
In 2023, Australia became the first country to allow authorized psychiatrists to prescribe psilocybin for treatment-resistant depression and MDMA for PTSD. Initially, the psychiatrist had to remain in the room during the entire session. Now, under the TGA's Authorised Prescriber Scheme, a psychiatrist can leave after drug administration, provided a qualified therapist stays.
Efficacy and Safety Concerns
These treatments have not undergone standard rigorous testing for dosing and side effects. Evidence for efficacy remains limited and mixed, and they are still considered experimental. Side effects can include anxiety, elevated heart rate, nausea, dizziness, psychosis, paranoid delusions, mood disturbances, and hallucinogen persisting perception disorder. A multi-country study found that about one-third of past-year psychedelic users experienced adverse effects. However, as of end 2025, no adverse events were reported among 65 psilocybin and 123 MDMA patients under Australia's model.
Debate Over Psychiatrist Presence
The Royal Australian and New Zealand College of Psychiatrists criticized the removal of the requirement for a psychiatrist to be physically present, noting that clinical trials included additional safeguards not replicated in private practices. Others argue that requiring a psychiatrist makes treatment too expensive and inaccessible, potentially driving patients to unregulated illegal sources with unknown potency and contaminants.
Risks of Commercialization
Experts warn against hype and commercialization, citing Australia's medicinal cannabis rollout as a cautionary tale where manufacturers ran clinics and supplied products without proper checks. Companies are already increasing production to meet potential demand, and marketing may overstate benefits.
Future Safeguards
To protect patients, proposed safeguards include standardizing practitioner training, establishing a national registry for patient and clinician outcomes overseen by the TGA, and ensuring regulatory changes are evidence-based. Ongoing robust research is essential, with regulation following evidence rather than preceding it.
